Quality Assurance Auditor II

Location: Richmond, Virginia
Pay Rate: $41.00–$43.97 per hour
Education: Bachelor's Degree or Equivalent Required
Experience: 2+ years of relevant Quality Assurance experience

Position Overview

We are seeking an experienced Quality Assurance Auditor II to support and enhance clinical auditing processes while ensuring compliance with applicable regulatory requirements and quality standards.

This position is ideal for a QA professional who can hit the ground running, independently conduct and lead audits, provide GxP guidance, identify quality and compliance risks, and effectively communicate findings to Operations teams, subject matter experts, clients, and management.

The successful candidate will have strong knowledge of GxP regulations and research guidelines, excellent analytical skills, and demonstrated experience conducting project-based, internal, and vendor audits.

Key Responsibilities

• Conduct and/or lead a variety of client, internal, GxP audits, and regulatory inspections as requested by senior management.

• Perform directed site, facility, vendor, and subcontractor audits.

• Conduct QA audits including:

  • Database audits

  • Clinical Study Report audits

  • Sample results table audits

  • Process audits

  • Vendor audits

  • Other quality assurance and process improvement activities

• Provide GxP consultation and quality assurance support to project teams and external clients.

• Lead process audits and participate as a co-auditor on more complex system audits.

• Evaluate audit results, identify potential compliance risks, and assess impacts.

• Prepare clear and comprehensive audit findings and related documentation.

• Present audit findings and other quality-related information to Operations staff, subject matter experts, internal teams, clients, and management.

• Serve as a knowledgeable resource to operational departments regarding audit practices and quality assurance requirements.

• Support continuous improvement initiatives and identify opportunities to strengthen quality processes.

• Apply root cause analysis and risk assessment techniques to quality issues.

• Work collaboratively with cross-functional teams to resolve audit findings and quality concerns.

• Perform additional QA activities as assigned.

Required Qualifications

• Bachelor's degree or equivalent relevant academic/vocational qualification.

• 2+ years of previous Quality Assurance experience or comparable experience providing the knowledge and skills required for the position.

• Demonstrated experience conducting and/or leading project-based, internal GxP, and vendor audits.

• Thorough knowledge of GxP requirements and applicable regional research regulations and guidelines.

• Strong understanding of quality systems and clinical research processes.

• Experience preparing, documenting, and presenting audit findings.

• Strong problem-solving, risk assessment, and impact analysis abilities.

• Demonstrated experience with root cause analysis.

• Excellent written and verbal communication skills.

• Strong negotiation and conflict-management skills.

• Ability to work independently and manage multiple priorities.

• Flexible and adaptable in a changing work environment.

• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit for business travel.

Equivalent combinations of education, training, and directly related experience may be considered in lieu of specific requirements where applicable.

Knowledge, Skills & Abilities

• Strong knowledge of GxP regulations and relevant research guidelines.

• Proven ability to conduct high-quality audits with limited supervision.

• Excellent attention to detail and documentation skills.

• Strong organizational and time-management abilities.

• Ability to communicate effectively with diverse groups, including Operations staff, SMEs, clients, and management.

• Ability to analyze complex information and make sound quality and compliance assessments.

• Ability to manage competing priorities and changing workloads.

• Ability to perform effectively in a fast-paced environment.

• Strong interpersonal and collaboration skills.

• Ability to work under pressure and meet deadlines.

Working Environment

• Work may be performed in an office, laboratory, and/or clinical environment.

• Potential exposure to biological fluids and infectious organisms may occur depending on the assigned work environment.

• Exposure to standard electrical office equipment.

• Personal protective equipment may be required, including protective eyewear, garments, and gloves.

Physical Requirements

• Ability to work in an upright and/or stationary position for approximately 6–8 hours per day.

• Frequent mobility throughout the work environment.

• Repetitive hand movements, including frequent use of fingers, hands, and wrists.

• Ability to crouch and stoop occasionally, with frequent bending and twisting of the upper body and neck.

• Ability to lift and carry light to moderate loads, including luggage and laptop equipment, up to approximately 15–20 pounds.

• Ability to access and use various computer software applications.

• Ability to effectively communicate information verbally and in writing.

• Ability to listen to and understand information presented by others.

• Frequent interaction with individuals and diverse groups to obtain and communicate information.

• Ability to perform a wide range of variable tasks in response to changing priorities and conditions.

• Ability to multitask and perform effectively under stress.

• Regular and consistent attendance required.

Schedule & Additional Information

• Shift: N/A

• Assessment Requirements: N/A

• Required PPE/Dress Code: None specified

• Travel: Business travel may be required; valid driver's license and corporate credit card eligibility required.

Compensation

$41.00–$43.97 per hour

This position is designed for an experienced QA professional who can quickly take ownership of auditing responsibilities and contribute to maintaining strong clinical, regulatory, and GxP quality standards.

Pay Details: $41.00 to $43.97 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://adecco-de.live/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.